Being Responsible for Ourselves HIV Risk Reduction for Black MSM
NCT02561286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 595
Last updated 2015-09-29
Summary
The incidence of HIV/AIDS among African American men who have sex with men (MSM) is alarming, and the public health response to this urgent situation has been hampered by a lack of sexual risk reduction interventions with solid evidence of efficacy in this population. Accordingly, the broad, long-term objective of the proposed research is to identify interventions to reduce the risk of sexually transmitted infection (STI) among African American MSM. This application seeks funds to develop and test the efficacy of a theory-based, contextually appropriate behavioral intervention to reduce sexual risk behavior among African American MSM. Intervention development will be guided by social cognitive theory, the theory of planned behavior, qualitative information from focus groups, and findings from a longitudinal survey of men from the study population. A one-on-one intervention will be utilized to address the specific prevention needs of each man and to allay participants' concerns about revealing their sexual involvement with men by virtue of participating in a group or workshop intervention. The study will utilize a randomized controlled trial design, with baseline, immediate post intervention, and 6 and 12 months post intervention assessments. The participants will be African American MSM who will be randomized to a one-on-one sexual risk reduction intervention or a one-on-one health promotion intervention that will serve as the control condition. The primary outcome is consistent condom use during anal and vaginal intercourse. The study will test whether the intervention increases the consistent use of condoms during anal intercourse, the primary outcome, whether it decreases other sexual risk behaviors, and whether social cognitive theory variables mediate the effects of the intervention on consistent condom use. This study will provide an urgently needed intervention to reduce the risk of HIV and other STIs in one of the highest risk populations in the United States.
Conditions
- Human Immunodeficiency Virus Infection (HIV)
- Sexually Transmitted Disease (STD)
Interventions
- BEHAVIORAL
-
BRO HIV Risk Reduction Intervention
BRO HIV Risk Reduction Intervention was designed to strengthen outcome expectancies supporting condom use and other sexual risk reduction strategies and skill and self-efficacy to use condoms and reduce sexual risk behaviors. It consisted of three 90-min one-on-one individual sessions implemented during 3 consecutive weeks by specially trained facilitators using standardized intervention manuals. Sessions 1 and 2 included take-home assignments that the participants reviewed at the subsequent session. The delivery of the intervention was tailored to the information that the participants provided during the sessions, including the context in which behaviors occurred and participants' motivation for the behaviors.
- BEHAVIORAL
-
Health Promotion Intervention
Health Promotion Intervention was designed to provide a control for "Hawthorne effects," reducing the likelihood that the HIV/STI risk-reduction intervention's effects could be attributed to non-specific features, including special attention. It focused on increasing physical activity and fruit-and-vegetable consumption and decreasing fat consumption to reduce the risk of chronic diseases, including heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among African Americans It also consisted of three 90-min one-on-one individual sessions implemented during 3 consecutive weeks by specially trained facilitators using standardized intervention manuals.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH - lead OTHER
Principal Investigators
-
John B Jemmott III, PhD · University of Pennsylvania
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2012-05-31
- Completion
- 2012-05-31
Countries
- United States
Study Locations
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